To be fair, says Brian Alverson, MD, also a pediatric hospitalist at Hasbro Children’s Hospital, physicians also contribute to overuse of antibiotics by ordering tests that drive up their inappropriate use. An X-ray might show small areas of lung atelectasis, which could be interpreted as pneumonia. A CBC test with an elevated white count could trigger an antimicrobial order. For the record, Dr. Alverson says neither test is indicated on a routine basis in the setting of bronchiolitis.
Over-the-Counter Risk
American consumers purchase 95 million packages of over-the-counter (OTC) cough and cold preparations for their sick children each year, according to the Consumer Healthcare Products Association. Many in the scientific community, including the American Academy of Pediatrics (AAP) and Wayne Snodgrass, MD, of the University of Texas Medical Branch’s department of pharmacology in Galveston, have pressed for more regulatory action, pointing to published evidence that ingredients such as brompheniramine are no more effective than a placebo in stopping a cough.6,7 Prompted by reports of two deaths in children, the FDA last October recommended that OTC cough-and-cold products not be given to infants or children under age 2. The FDA also is reviewing its recommendations for children ages 2 to 11.
Since initiation of the Pediatric Exclusivity Provision, which extends six months of patent exclusivity for products undergoing testing in children, and passage of the Best Pharmaceuticals for Children Act (BPCA) in 2002, more than 133 labeling changes have resulted from 300 pediatric-specific studies. (For a comprehensive list of the labeling changes, visit www.fda.gov/oc/opt/pediatriclabeling.html.)
In addition, National Institutes of Health prioritization of medications for future research studies in youth now consider frequency-of-use data from insured populations, Dr. Zito says. These changes have led to some improvements—for example, “black box” warnings against stimulants given for ADHD and selective serotonin reuptake inhibitors (SSRIs) prescribed for depression. The moves also underline the need for more research.
Key safety questions remain in the pediatric community. For example, is it acceptable to calculate smaller doses by weight of drugs approved safe for adults? On this subject, pediatric hospitalists “are woefully, inadequately armed with evidence,” Dr. Alverson says. “We routinely use medications in children where the dosing is arbitrarily guessed at.”
A 2007 study conducted by Dr. Shah and colleagues validates this point. The study found that most of the children hospitalized at 31 tertiary-care pediatric hospitals received at least one medication outside the FDA product license indication.8 Although the finding does not necessarily mean the medications were inappropriate, it highlights the dearth of studies establishing the proper dosages and uses of medications in children, and the long-term outcomes of their usage.
One way in which hospitalists can help is educating parents about the perils of OTC medicines, Dr. Shen says. An example of a safety concern is parents giving their children acetaminophen (Tylenol) and ibuprofen (Motrin) together; evidence shows that this kind of dosing error by parents is relatively common.
Fill the Knowledge Gap
When it comes to choosing medications and dosages for children, pediatric hospitalists often make treatment decisions based on their clinical experience, observational studies, or by extrapolating data from adult studies.
“There are countless examples of places where evidence-based physicians must still make educated guesses,” Dr. Alverson says.
However, experts point out that children are not “little adults.” Extrapolating from adult data can lead to unpredictable clinical responses and the possibility of overmedication. Going forward, the trick will be to tease out, with rigorous research, which medications—and at which dosages—are best for which kids.
Dr. Alverson suggests hospitalists stay on top of the literature, take advantage of all available CME, and plug into a listserv, such as the American Academy of Pediatrics’ HM listserv (download instructions and an enrollment form at www.aap.org/sections/hospcare/listservSOHM.pdf).